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# PhRMA Proposes Changes to Opioid Benefit/Risk Framework
- URL: https://www.fdaweb.com/phrma-proposes-changes-to-opioid-benefit-risk-framework/
- Published: 2019-09-18T12:00:00.000Z
- Updated: 2026-09-15T01:50:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145034

Pharmaceutical Research and Manufacturers of America (PhRMA) says it supports FDA efforts to develop a benefit/risk framework for approving prescription opioid medicines that accounts for public health concerns. In its [comment](https://www.regulations.gov/contentStreamer?documentId=FDA-2019-D-1536-0032&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) on an agency draft guidance, PhRMA proposes: 

- FDA revise the draft to state more clearly that under the Federal Food, Drug, and Cosmetic Act (FFDCA), for purposes of approval, an NDA need not contain evidence comparing an opioid’s safety or effectiveness to another drug;
- The draft guidance should clearly distinguish between information that FDA must evaluate under the FFDCA for approval of an NDA and optional information that could provide additional context for considerations within a benefit/risk framework but is not required for approval under the FFDCA.
- FDA continue its commitment to encourage development of abuse-deterrent formulations and using a flexible, adaptive approach to working with industry on the evaluation and labeling of potential abuse-deterrent formulations.